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出境医 / 临床实验 / Analysis of Endotoxin Activity in Patients With ECMO

Analysis of Endotoxin Activity in Patients With ECMO

Study Description
Brief Summary:
Extra-corporeal membrane oxygenation (ECMO) can temporarily help patients gain time to wait for cardiopulmonary recovery or further treatment in patients with cardiopulmonary failure. Whether the blood flow provided by the ECMO can maintain the perfusion of various organs is an important factor affecting survival. Some ECMO patients died after the complication of sepsis. Our previous pilot analysis has recognized several ECMO patients with complicated sepsis has high endotoxin activity level. Endotoxemia can also occur in heart surgery and after cardiopulmonary bypass, trauma, organ transplantation, and out-of-hospital cardiac arrest patients. These trials used endotoxin activity analysis (EAA, EAATM, Spectral Diagnostics Inc., Canada) to analyze endotoxin activity. In addition, studies have indicated that the combination of procalcitonin (PCT) concentration and EAA activity can improve the accuracy of predicting sepsis. The primary aim of this study is to detect endotoxin activity in patients with ECMO support and compare whether the prognosis was associated with different level of EAA activity. The secondary aims are to analyze the risk factors leading to high EAA activity and investigate the diagnostic value of septic shock combining PCT examination. We suggest that the results of this study may help the ECMO medical team identify patients at high risk for septic shock and conduct adequate managements to improve patient survival and quality of life after survival.

Condition or disease Intervention/treatment
Cardiovascular Shock Respiratory Failure Device: Extra-corporeal membrane oxygenation

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Endotoxin Activity in Patients With Extracorporeal Membrane Oxygenation Life Support System
Actual Study Start Date : August 21, 2019
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
ECMO patients
Patients with ECMO support
 Device: Extra-corporeal membrane oxygenation
Cardiovascular shock patients received extra-corporeal membrane oxygenation suppot.
Outcome Measures
Primary Outcome Measures :
  1. Endotoxin activity level [ Time Frame: within 48 hours ]
    Endotoxin activity level is measured by endotoxin activity analysis kit


Secondary Outcome Measures :
  1. Endotoxin activity level [ Time Frame: within 24 hours ]
    Endotoxin activity level is measured by endotoxin activity analysis kit

  2. Endotoxin activity level [ Time Frame: within 72 hours ]
    Endotoxin activity level is measured by endotoxin activity analysis kit

  3. Endotoxin activity level [ Time Frame: within 96 hours ]
    Endotoxin activity level is measured by endotoxin activity analysis kit

  4. Procalcitonin level [ Time Frame: within 48 hours ]
    Procalcitonin level in ECMO patients

  5. Cystatin C level [ Time Frame: within 48 hours ]
    Cytatin C level in ECMO patients

  6. Diamine oxidase level [ Time Frame: within 48 hours ]
    Diamine oxidase level in ECMO patients


Biospecimen Retention:   Samples Without DNA
serum

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Paitents with extra-corporeal membrane oxygenation support
Criteria

Inclusion Criteria:

  • patients with ECMO support

Exclusion Criteria:

  • < 20 years old or > 90 years old
  • not be able to collect blood sample within 48 hours after placement of ECMO
  • change plan to palliative care and plan to remove ECMO
  • non-native speakers
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Yu-Chang Yeh, MD, PhD 886-9-10513711 tonyyeh@ntuh.gov.tw

Locations
Layout table for location information
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Yu-Chang Yeh, M.D, Ph.D.    886-910513711    tonyyeh@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yu-Chang Yeh, MD, PhD National Taiwan University Hospital
Tracking Information
First Submitted Date June 2, 2019
First Posted Date June 7, 2019
Last Update Posted Date January 15, 2021
Actual Study Start Date August 21, 2019
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2019) 		Endotoxin activity level [ Time Frame: within 48 hours ]
Endotoxin activity level is measured by endotoxin activity analysis kit
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 5, 2019)
  • Endotoxin activity level [ Time Frame: within 24 hours ]
    Endotoxin activity level is measured by endotoxin activity analysis kit
  • Endotoxin activity level [ Time Frame: within 72 hours ]
    Endotoxin activity level is measured by endotoxin activity analysis kit
  • Endotoxin activity level [ Time Frame: within 96 hours ]
    Endotoxin activity level is measured by endotoxin activity analysis kit
  • Procalcitonin level [ Time Frame: within 48 hours ]
    Procalcitonin level in ECMO patients
  • Cystatin C level [ Time Frame: within 48 hours ]
    Cytatin C level in ECMO patients
  • Diamine oxidase level [ Time Frame: within 48 hours ]
    Diamine oxidase level in ECMO patients
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis of Endotoxin Activity in Patients With ECMO
Official Title Analysis of Endotoxin Activity in Patients With Extracorporeal Membrane Oxygenation Life Support System
Brief Summary Extra-corporeal membrane oxygenation (ECMO) can temporarily help patients gain time to wait for cardiopulmonary recovery or further treatment in patients with cardiopulmonary failure. Whether the blood flow provided by the ECMO can maintain the perfusion of various organs is an important factor affecting survival. Some ECMO patients died after the complication of sepsis. Our previous pilot analysis has recognized several ECMO patients with complicated sepsis has high endotoxin activity level. Endotoxemia can also occur in heart surgery and after cardiopulmonary bypass, trauma, organ transplantation, and out-of-hospital cardiac arrest patients. These trials used endotoxin activity analysis (EAA, EAATM, Spectral Diagnostics Inc., Canada) to analyze endotoxin activity. In addition, studies have indicated that the combination of procalcitonin (PCT) concentration and EAA activity can improve the accuracy of predicting sepsis. The primary aim of this study is to detect endotoxin activity in patients with ECMO support and compare whether the prognosis was associated with different level of EAA activity. The secondary aims are to analyze the risk factors leading to high EAA activity and investigate the diagnostic value of septic shock combining PCT examination. We suggest that the results of this study may help the ECMO medical team identify patients at high risk for septic shock and conduct adequate managements to improve patient survival and quality of life after survival.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum
Sampling Method Non-Probability Sample
Study Population Paitents with extra-corporeal membrane oxygenation support
Condition
  • Cardiovascular Shock
  • Respiratory Failure
Intervention Device: Extra-corporeal membrane oxygenation
Cardiovascular shock patients received extra-corporeal membrane oxygenation suppot.
Study Groups/Cohorts ECMO patients
Patients with ECMO support
Intervention: Device: Extra-corporeal membrane oxygenation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 5, 2019) 		60
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2021
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients with ECMO support

Exclusion Criteria:

  • < 20 years old or > 90 years old
  • not be able to collect blood sample within 48 hours after placement of ECMO
  • change plan to palliative care and plan to remove ECMO
  • non-native speakers
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Yu-Chang Yeh, MD, PhD 886-9-10513711 tonyyeh@ntuh.gov.tw
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03978728
Other Study ID Numbers 201811061RINC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Yu-Chang Yeh, MD, PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date June 2020

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